In the field of pharmacology, DMF refers to the “drug master file”. This file or document is submitted to a drug regulating authority as part of a requirement for a new drug for example or as proof of collaboration between two or more pharmaceutical agencies or organizations. In general, companies that manufacture drugs are not required to submit the DMF to the corresponding regulating agency or authority. In the case of the US, the US Food and Drugs Administration does not require all pharmaceutical companies to submit the DMF to them unless for specific cases wherein this document is required.

The DMF or drug master file basically contains confidential information regarding a particular drug. The facilities and processes involved in the manufacture of a drug are contained in detail on the DMF. All other articles and documentations regarding the packaging and storage of the drug are also included in the drug master file. Drug chemistry, content, effects, and side effects are also important components of the DMF or drug master file. This is especially applicable to the details involving the drug’s so-called active ingredient. All the details regarding this particular ingredient must be included in the DMF especially when a pharmaceutical company needs to submit this document as part of the requirement for NDA or New Drug Application. In this specific instance, the DMF will serve as the document for review and testing of the US FDA for example in terms granting the company with the necessary approval and certifications for commercialization.

The DMF may also be necessary for some drug companies to help protect themselves with their intellectual property for some drug ingredients or components. This is applicable to situations wherein two or more drug companies collaborate to manufacture or create a new drug for a certain disease or illness. In this particular case, the DMF is also submitted as part of the disclosure requirement of regulatory agencies like the US FDA.